Senior Mechanical Engineer - Medical Device

Location : Somerville, MA Senior Mechanical Engineer – Medical Device Overview : Micro-Leads is a fast-paced early-stage company developing an injectable medical device to treat people with chronic pain with greater efficacy. Our company has extensive expertise in precision implantable medical devices for nerve stimulation and neuromodulation. Role Summary : The primary role of this position is to design and build injectable electrodes for needle delivery and implantable pulse generator housings for next-generation neurostimulator devices. The individual will design electrodes for stimulation and nerve recordings. Additionally, the candidate will prototype, build, and conduct mechanical integrity and related tests. The individual will also develop manufacturing processes and work with vendors to manufacture components. The candidate must have a significant background in medical device development, implantable electrodes, process development, verification, and validation. The individual should be hands-on and have direct experience working with vendors and in design transfer to contract manufacturers. Responsibilities : Mechanical design of implantable electrodes for neuromodulation End-to-end development of assembly and manufacturing processes Design of processes for thin substrate laminations and bonding techniques Design of microscale assembly techniques, including scaling to manufacturability Develop micro-molding, thermoforming, and lamination methods for thin substrates and catheters Create 3D assemblies and technical drawings of electrodes and implantable housings using SolidWorks and AutoCAD Identify, source, and manage vendors to obtain hardware components on schedule (e.g., procuring materials, services from machine shops or 3D printing houses, contract manufacturing) Develop mechanical testing structures and set up accelerated lifetime tests Manage engineering personnel as necessary (e.g., junior engineers, technicians, co-ops) Adhere to Micro-Leads quality management system, understand essential regulatory requirements, and follow standard operating procedures Maintain design control requirements related to Micro-Leads’ QMS, including developing design inputs / outputs, risk management, verification, and validation Minimum qualifications : B.S. in Mechanical or Biomedical Engineering, M.S. 2-4 years of related professional experience post-Bachelor’s Degree Desired qualifications & experience : Ability to multi-task and work effectively as part of a small team Excellent benchtop capability, including dexterity to manipulate small structures under a stereomicroscope Familiarity with standard tooling for rapid prototyping (e.g., drill presses, saws, welding, soldering, CNC mills) Experience with precision microscale assembly of silicone electrodes using processes such as injection molding, casting, micro-fluidic molding, etc. Experience with Class III implantable systems and hermetic manufacturing methods Experience with precision microscale assembly of silicone electrodes using processes such as injection molding, thermoforming, lamination, micro-molding, etc. Benefits : Medical Insurance Dental Insurance Vision Insurance Stock Options #J-18808-Ljbffr